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FDA 510(k)

AccuFill Bone Substitute Material

K 號：K190814 · 2019-06-10

申請人Zimmer Knee Creations
決定日期2019-06-10
產品代碼MQV
諮詢委員會或
決定相當於

器材摘要

AccuFill Bone Substitute Material is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Knee Creations. It received FDA 510(k) clearance on 2019-06-10 under 510(k) number K190814. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AccuFill Bone Substitute Material?

AccuFill Bone Substitute Material is a medical device that received FDA 510(k) clearance on 2019-06-10. The listed applicant is Zimmer Knee Creations. The 510(k) number is K190814.

When did AccuFill Bone Substitute Material receive FDA 510(k) clearance?

AccuFill Bone Substitute Material received FDA 510(k) clearance on 2019-06-10, under 510(k) number K190814.

Who is the listed applicant for AccuFill Bone Substitute Material?

The FDA 510(k) record lists Zimmer Knee Creations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccuFill Bone Substitute Material?

The FDA product code for AccuFill Bone Substitute Material is MQV.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：MQV）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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